PMID- 35470997 OWN - NLM STAT- MEDLINE DCOM- 20220428 LR - 20220428 IS - 1724-5990 (Electronic) IS - 0393-5590 (Linking) VI - 39 IP - 2 DP - 2022 Apr 21 TI - Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study. LID - 2022-vol2 [pii] AB - Introduction: Some hemodialysis patients are reluctant to undergo COVID-19 vaccination for the fear of developing adverse events (AEs). The aim of this study was to verify the safety of the mRNA-1273 vaccine in hemodialysis patients. Methods: We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results: Overall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged >/=65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population. Conclusion: The RNA-1273 vaccine was associated with the development of transient AEs after the first and second doses in patients on chronic maintenance hemodialysis. They were mostly local, whereas systemic AEs were more prevalent after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae. CI - Copyright by Societa Italiana di Nefrologia SIN, Rome, Italy. FAU - Alfano, Gaetano AU - Alfano G AD - Nephrology, Dialysis and Transplant Unit, University Hospital of Modena, Modena, Italy; Clinical and Experimental Medicine Ph.D. Program, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Morisi, Niccolo AU - Morisi N AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Fontana, Francesco AU - Fontana F AD - Nephrology, Dialysis and Transplant Unit, University Hospital of Modena, Modena, Italy. FAU - Scarmignan, Roberta AU - Scarmignan R AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Tonelli, Laura AU - Tonelli L AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Ferri, Camilla AU - Ferri C AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Montani, Martina AU - Montani M AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Melluso, Andrea AU - Melluso A AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Giovanella, Silvia AU - Giovanella S AD - Clinical and Experimental Medicine Ph.D. Program, University of Modena and Reggio Emilia; Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Ligabue, Giulia AU - Ligabue G AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Mori, Giacomo AU - Mori G AD - Nephrology, Dialysis and Transplant Unit, University Hospital of Modena, Modena, Italy. FAU - Franceschini, Erica AU - Franceschini E AD - Clinic of Infectious Diseases, University Hospital of Modena, Modena, Italy. FAU - Guaraldi, Giovanni AU - Guaraldi G AD - Clinic of Infectious Diseases, University Hospital of Modena, Modena, Italy. FAU - Cappelli, Gianni AU - Cappelli G AD - Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Magistroni, Riccardo AU - Magistroni R AD - Nephrology, Dialysis and Transplant Unit, University Hospital of Modena, Modena, Italy; Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. FAU - Donati, Gabriele AU - Donati G AD - Nephrology, Dialysis and Transplant Unit, University Hospital of Modena, Modena, Italy; Surgical, Medical and Dental Department of Morphological Sciences, Section of Nephrology, University of Modena and Reggio Emilia, via del Pozzo 71, 41124 Modena, Italy. LA - eng PT - Journal Article DEP - 20220421 PL - Italy TA - G Ital Nefrol JT - Giornale italiano di nefrologia : organo ufficiale della Societa italiana di nefrologia JID - 9426434 RN - 0 (COVID-19 Vaccines) RN - EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273) SB - IM MH - 2019-nCoV Vaccine mRNA-1273 MH - Aged MH - *COVID-19/prevention & control MH - COVID-19 Testing MH - *COVID-19 Vaccines/adverse effects MH - Fatigue/etiology MH - Humans MH - Nausea MH - Renal Dialysis MH - Retrospective Studies MH - SARS-CoV-2 MH - Vomiting OTO - NOTNLM OT - COVID-19 OT - SARS-COV-2 OT - hemodialysis OT - mRNA-1273 OT - safety OT - side effects OT - vaccine EDAT- 2022/04/27 06:00 MHDA- 2022/04/29 06:00 CRDT- 2022/04/26 08:54 PHST- 2022/04/26 08:54 [entrez] PHST- 2022/04/27 06:00 [pubmed] PHST- 2022/04/29 06:00 [medline] AID - 39-02-2022-05 [pii] PST - epublish SO - G Ital Nefrol. 2022 Apr 21;39(2):2022-vol2.